FDA Announces Reporting Requirements for Foods Susceptible to Food-Borne Illness

The Food and Drug Administration (FDA) announced a proposed rule on Monday, which would “establish additional traceability recordkeeping requirements” for foods on a specific list, including fruits, vegetables, some fish, nut butters, and leafy greens.

The announcement said, ”improved traceability, as envisioned by the proposed rule, would allow the FDA to more quickly identify the source of a contaminated product, reduce the scope of product recalls, and conduct more timely root-cause investigations to learn more about how contamination occurred in order to prevent future outbreaks.”

The rule, Requirements for Additional Traceability Records for Certain Foods, would, if finalized, standardize the necessary data and information sent between supply chain organizations and companies to provide more accurate and rapid tracing of foodborne illnesses. The release said current FDA regulations require some recordkeeping, but do not have enough to link food through each supply chain point, causing difficulty in tracing. It also said paper-based recordkeeping and lack of a universal system adds to tracing difficulties.

The Center for Food Safety said in a press release that this action follows a settlement in litigation filed by the organization in 2018 against the FDA because they were allegedly not meeting the Food Safety Modernization Act reporting requirements.

“We are pleased FDA has now released this important rule, as required by the Court order and settlement in our litigation to compel compliance with FSMA. It should not have taken litigation for FDA to publish this proposed rule but now that it is out, we will be analyzing the merits of the proposal closely and continue to ensure the agency follows the law in finalizing the rule,” said Ryan Talbott, attorney for the Center for Food Safety.

The Consent Decree in the case required the FDA to publish a list of high-risk foods and reporting requirements by September 8, 2020, and place the list of foods on the FDA website after the rule is published in the Federal Register.

Under the proposed rule, manufacturers or others involved in the food chain for items on the list will create and maintain records, which include Critical Tracking Events like transforming or shipping, and Key Data Elements like dates and descriptions. The companies will also be required to keep internal records. The FDA stated that if an outbreak of a foodborne illness occurs, the rule would allow the FDA to require a spreadsheet with the information within 24 hours. They recommend that the records are kept electronically, however, paper copies are allowed.

The public is able to comment on the rule for 120 days after the rule is published in the Federal Register on Wednesday, and the FDA said it plans to hold three meetings for public comment during the 120-day time period.